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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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April 01, 2010 |
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Ramada Plaza Basel , Basel, Switzerland
Sep 23 2010 8:00AM - Sep 24 2010 5:30PM
This course will offer insight into the compilation of the eCTD, share experience and best practise gained during eCTD submissions in the EU, and the eCTD review process. The focus will be on practical experience gained in preparing and submitting electronically. Key Topics: - Overview of eCTD readiness at the agencies
- Impact of the eCTD on regulatory processes and procedures
- Practical experience of submitting an eCTD in the EU
- eCTD compilation and life cycle
- Document granularity and readiness
- Regulatory strategy facing technical issues
- Specifications and standards versus regions and procedures
- NeeS and its role in eSubmission
Event Code:
10545
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Organized by:
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DIA Europe |
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Invited Speakers:
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call contact
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Deadline for Abstracts:
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call contact
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Registration:
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DIA Europe TEL.: +41 61 225 51 51FAX: +41 61 225 51 52
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E-mail:
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DIAEUROPE@DIAEUROPE.ORG
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WWW: Kai Garlipp,
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